1429. Real-World Study of Patients with Uncomplicated Urinary Tract Infection in the United States: High-Risk Comorbid Conditions and Burden of Illness

Abstract Background Urinary tract infections (UTIs) are associated with significant morbidity and economic burden, particularly in the elderly and patients with comorbidities. We used real-world data (RWD) to assess healthcare resource use (HRU) and costs in patients with uncomplicated UTI (uUTI) and high-risk comorbid conditions in the US. Methods This was a retrospective cohort study (IBM MarketScan RWD, commercial/Medicare Supplemental claims January 1, 2014–December 31, 2017) of females ≥ 12 years of age with uUTI who had an oral antibiotic prescription ± 5 days of uUTI diagnosis (index date) and continuous health-plan enrollment for ≥ 1 year pre-/post index date. Five high-risk cohorts and matched-control cohorts (baseline age, region) were identified: controlled type 2 diabetes (T2D), mild/moderate chronic kidney disease (CKD), recurrent UTI (rUTI), elderly (ELD), and postmenopausal (PMP) (Table 1). Sample sizes were balanced via random match selection (1:5 case:control). uUTI-related HRU and costs were compared between cases and controls (index episode/1-year follow-up) using multivariable generalized linear models. Table 1. Cohort assignment for high-risk cohorts and controls Results Of 339,100 patients with uUTI, case/control cohorts comprised T2D, n=15,423/n=77,115; CKD, n=1041/n=5205; rUTI, n=7937/n=39,685; ELD, n=23,666/n=118,330; and PMP, n=105,608/n=211,216 patients. HRU trends across cohorts varied. During 1-year followup, outpatient visits were significantly different for cases versus controls in the T2D, rUTI, and PMP cohorts (p ≤ 0.0079), with higher case than control values in the rUTI and PMP cohorts; pharmacy claims were significantly higher for rUTI, ELD, and PMP cases, and inpatient visits were significantly higher for ELD and PMP cases, versus controls (all p < 0.0001; Table 2). Adjusted total uUTI-related costs (emergency room + outpatient + pharmacy) were significantly different (p < 0.0001) for cases versus controls at index episode and during follow-up in all cohorts except CKD: case values were higher than controls at index episode and during follow-up in the T2D cohort, and during follow-up in the rUTI and ELD cohorts (Table 3). Table 2. uUTI-related HRU* for cases versus controls according to high-risk cohort Table 3. uUTI-related costs* for cases versus controls according to high-risk cohort Conclusion Females in some high-risk case cohorts had higher uUTI-related HRU and costs versus controls. Further studies of relationships between comorbidities and uUTI burden are needed. Disclosures Madison T. Preib, MPH, STATinMED Research (Employee, Former employee of STATinMED Research, which received funding from GlaxoSmithKline plc. to conduct this study) Alen Marijam, MSc, GlaxoSmithKline plc. (Employee, Shareholder) Fanny S. Mitrani-Gold, MPH, GlaxoSmithKline plc. (Employee, Shareholder) Daniel C. Gibbons, PhD, GlaxoSmithKline plc. (Employee, Shareholder) Xiaoxi Sun, MA, STATinMED Research (Employee, Employee of STATinMED Research, which received funding from GlaxoSmithKline plc. to conduct this study) Christopher Adams, MPH, STATinMED Research (Employee, Employee of STATinMED Research, which received funding from GlaxoSmithKline plc. to conduct this study) Ashish V. Joshi, PhD, GlaxoSmithKline plc. (Employee, Shareholder)

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1422. Real-World Study of the Effects of Inappropriate or Suboptimal Treatment on the Burden of Illness Among Patients with Uncomplicated Urinary Tract Infection and High-Risk Comorbid Conditions in the United States

Open Forum Infectious Diseases ◽

10.1093/ofid/ofab466.1614 ◽

2021 ◽

Vol 8 (Supplement_1) ◽

pp. S794-S795

Author(s):

Madison T Preib ◽

Alen Marijam ◽

Fanny S Mitrani-Gold ◽

Daniel C Gibbons ◽

Xiaoxi Sun ◽

...

Keyword(s):

Urinary Tract ◽

High Risk ◽

Real World ◽

Index Date ◽

The United States ◽

Uncomplicated Urinary Tract Infection ◽

Comorbid Conditions ◽

Tract Infections ◽

High Risk Cohort

Abstract Background Urinary tract infections (UTIs) are associated with significant morbidity and economic burden. Nitrofurantoin (NFT) and fosfomycin are among the first-line treatments for uncomplicated UTI (uUTI) recommended by Infectious Diseases Society of America (IDSA) 2011 guidance. We used real-world data (RWD) to assess patterns of appropriate and optimal (AP&OP) and inappropriate or suboptimal (IA/SO) antibiotic (AB) prescribing (RX), and related healthcare resource use (HRU) and costs, in US uUTI patients with high-risk comorbid conditions. Methods This was a retrospective cohort study of RWD (IBM MarketScan, commercial/Medicare Supplemental claims January 1, 2014–December 31, 2017) in females ≥ 12 years of age with uUTI, who had an oral AB prescription ± 5 days of uUTI diagnosis (index date) and continuous health-plan enrollment ≥ 1 year pre-/post-index date. Patients were stratified into high-risk cohorts (Table 1) and by AB RX (AP&OP and IA/SO) during first uUTI episode (within 28 days of index). AP&OP RX followed IDSA guidance, IA RX did not; SO RX was considered a proxy for treatment failure (e.g., AB switch or a second UTI diagnosis [acute care setting] in index episode). Sample size was balanced via random match selection, AP&OP:IA/SO ratio 1:5 (age and region). uUTIrelated HRU and costs were compared between cohorts (at index episode and 1-year follow-up) via multivariable analysis. Table 1. High-risk cohorts identified in the study Results IA/SO AB RX was highest in the elderly cohort (94.3%, likely influenced by renal impairment/no NFT RX in this group) and > 90% in other cohorts; AP&OP AB RX was highest in the postmenopausal cohort (9.0%). IA/SO AB RX in all cohorts was associated with significantly higher uUTI-related HRU (outpatient visits and pharmacy claims) per index episode/during follow-up versus AP&OP AB RX (p ≤ 0.0237, Table 2). IA/SO AB RX in all cohorts was associated with significantly higher adjusted total costs per index episode/during follow-up versus AP&OP AB RX (p < 0.05; Table 3). Table 2. uUTI-related HRU* per patient according to high-risk cohort and stratified by AB RX Table 3. uUTI-related costs* per patient according to high-risk cohort and stratified by AB RX Conclusion Over 90% of females in each high-risk cohort identified had IA/SO AB RX (outside IDSA 2011 guidance for uUTI treatment), leading to high HRU and cost burden. This suggests an unmet need for uUTI symptom relief, new treatments, training, and improved RX practices in the US and, furthermore, a need for additional research in this area. Disclosures Madison T. Preib, MPH, STATinMED Research (Employee, Former employee of STATinMED Research, which received funding from GlaxoSmithKline plc. to conduct this study) Alen Marijam, MSc, GlaxoSmithKline plc. (Employee, Shareholder) Fanny S. Mitrani-Gold, MPH, GlaxoSmithKline plc. (Employee, Shareholder) Daniel C. Gibbons, PhD, GlaxoSmithKline plc. (Employee, Shareholder) Xiaoxi Sun, MA, STATinMED Research (Employee, Employee of STATinMED Research, which received funding from GlaxoSmithKline plc. to conduct this study) Christopher Adams, MPH, STATinMED Research (Employee, Employee of STATinMED Research, which received funding from GlaxoSmithKline plc. to conduct this study) Ashish V. Joshi, PhD, GlaxoSmithKline plc. (Employee, Shareholder)

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1439. Epidemiology and 12- Month Antibiotic Use in the Outpatient Setting among Adult Patients with Complicated Urinary Tract Infections: A Retrospective Database Analysis

Open Forum Infectious Diseases ◽

10.1093/ofid/ofab466.1631 ◽

2021 ◽

Vol 8 (Supplement_1) ◽

pp. S801-S801

Author(s):

Thomas Lodise ◽

Janna Manjelievskaia ◽

Matthew Brouillette ◽

Kate Sulham

Keyword(s):

Urinary Tract ◽

Urinary Tract Infections ◽

Index Date ◽

Panel Member ◽

Outpatient Setting ◽

Adult Patients ◽

Review Panel ◽

Ibm Watson ◽

Tract Infections

Abstract Background Complicated urinary tract infections (cUTI) are one of the most common bacterial infections and represent substantial burden to the health care system. Here, we examine the epidemiology and treatment patterns associated with cUTI in a large US database containing longitudinal inpatient (IP) and outpatient (OP) patient-level data. Methods We conducted a retrospective cohort study of adult patients in the IBM MarketScan® Commercial or Medicare Supplemental Databases with at least 1 IP or non-diagnostic OP claim with a diagnosis for cUTI between January 1, 2017 and June 30, 2019. Patients meeting the following criteria were included for analysis: (1) ≥18 years of age on the index date, (2) ≥6 months of continuous enrollment (CE) with medical and pharmacy benefits prior to the index date, (3) ≥12 months of CE following the index date or evidence of death, and (4) no evidence of a prior cUTI during the 6-month baseline period. Demographics and clinical characteristics were quantified. Patients were classified as IP if they were hospitalized during 30-day post index date; remaining patients were classified as OP. Antibiotics received in the OP setting in the 12-months post index date were examined. Results 95,423 patients met study criteria. Most (86.4%) patients were Commercially insured, mean (SD) age was 53.6 (18.1) and 70.4% were female. Mean baseline Charlson Comorbidity Index was 0.77. During the 30-day post index date, 22.2% were treated as IP and 77.8% were strictly treated as OP. In the 12-month OP follow-up period among index IP, 78.2% required ≥ 2 antibiotics, 38.2% required ≥4 antibiotics, and 41.6% received an IV antibiotic. In the 12-month OP follow-up period among index OP, 81.8% required ≥2 antibiotics, 38.2% required ≥4 antibiotics, and 46.8% received an IV antibiotic. For both IP and OP, fluoroquinolones were the most common oral antibiotic class (57.7%), followed by cephalosporins (39.2%), penicillins (30.3%), trimethoprim-sulfamethoxazole (29.8%), and nitrofurantoin (25.2%). Cephalosporins were the most common IV antibiotic class (38.5%). Conclusion Regardless of index treatment setting, approximately 40% of all cUTI patients required ≥4 antibiotic therapy and almost half with receive an IV antibiotic in the outpatient setting in the 12-months post index date. Disclosures Thomas Lodise, Jr., PharmD, PhD, Astra-Zeneca (Consultant)Bayer (Consultant)DoseMe (Consultant, Advisor or Review Panel member)ferring (Consultant)genentech (Consultant)GSK (Consultant)Melinta (Consultant)merck (Consultant, Independent Contractor)nabriva (Consultant)paratek (Consultant, Advisor or Review Panel member, Speaker’s Bureau)shionogi (Consultant, Advisor or Review Panel member, Speaker’s Bureau)Spero (Consultant)tetraphase (Consultant)Venatrox (Consultant) Thomas Lodise, Jr., PharmD, PhD, Melinta Therapeutics (Individual(s) Involved: Self): Consultant; Merck (Individual(s) Involved: Self): Consultant, Scientific Research Study Investigator; Paratek (Individual(s) Involved: Self): Consultant; Shionogi (Individual(s) Involved: Self): Consultant, Speakers’ bureau; Spero (Individual(s) Involved: Self): Consultant; Tetraphase Pharmaceuticals Inc. (Individual(s) Involved: Self): Consultant Janna Manjelievskaia, PhD, MPH, IBM Watson Health (Employee)Spero Therapeutics (Consultant) Matthew Brouillette, MPH, Spero Therapeutics, Inc. (Other Financial or Material Support, I am an employee of IBM Watson Health, who received funds from Spero Therapeutics, Inc. to conduct this analysis.) Kate Sulham, MPH, Spero Therapeutics (Consultant)

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1434. Treatment Patterns, Healthcare Resource Use, and Associated Costs in Females with Uncomplicated Urinary Tract Infection in the United States

Open Forum Infectious Diseases ◽

10.1093/ofid/ofab466.1626 ◽

2021 ◽

Vol 8 (Supplement_1) ◽

pp. S798-S799

Author(s):

Rena Moon ◽

Alen Marijam ◽

Fanny S Mitrani-Gold ◽

Daniel C Gibbons ◽

Alex Kartashov ◽

...

Keyword(s):

Applied Sciences ◽

Urinary Tract ◽

Resource Use ◽

Healthcare Resource ◽

Uncomplicated Urinary Tract Infection ◽

Healthcare Resource Use ◽

Ed Visits ◽

Tract Infections ◽

Switch Group

Abstract Background Urinary tract infections (UTIs) disproportionately affect women and are a substantial burden on healthcare systems. We assessed the effect of antibiotic (AB) switching on UTI recurrence, healthcare resource use (HRU), and related costs among adolescent and adult females in the US with uncomplicated UTIs (uUTIs). Methods This retrospective cohort study used US Optum claims data (United Healthcare, January 1, 2013–December 31, 2018). Eligible patients were females ≥ 12 years of age with an acute uUTI diagnosis at outpatient or emergency department (ED) visit (index date) and an oral AB prescription within ± 5 days of index. Patients with recurrent UTIs (rUTIs), defined as 2 UTI diagnoses (including index) in 6 months or ≥ 3 UTI diagnoses (including index) in 12 months, were included; those with complicated UTI were excluded. Patients were assigned to two groups: AB switch (≥ 2 filled prescriptions of different AB within 28 days post index [uUTI episode]) and no AB switch. Results In 5870 eligible patients (mean age 44.5 years; 76.6% White), ciprofloxacin (CIP; 38.6%), nitrofurantoin (NFT; 31.4%), and trimethoprim-sulfamethoxazole (TMP-SMX; 25.6%) were the most commonly prescribed first-line ABs at index, and 567 (9.7%) patients switched AB. CIP was switched to NFT and TMP-SMX in 2.0% and 1.7% of patients, respectively. NFT was switched to CIP and TMP-SMX in 2.6% and 1.5% of patients, respectively. TMP-SMX was switched to CIP and NFT in 3.0% and 2.4% of patients, respectively. During index visit, the AB switch group had higher mean ambulatory care and pharmacy claims (both p < 0.001), and higher total mean HRU costs (&2186.4) per patient compared with the no switch group (&1508.8; p = 0.011). More patients had rUTI in the AB switch group (18.9%) versus the no switch group (14.2%; p < 0.001), and more had ED visits in the AB switch group than the no switch group (p < 0.0001) (Table 1). During follow-up, the AB switch group had a higher mean number of uUTI episodes per patient (p < 0.001; Table 1), and more patients had UTI-related ED visits (10.8%) compared with the no switch group (7.7%; p = 0.010; Table 2). Table 1. Primary outcomes of uncomplicated UTI outpatients during January 1, 2013–December 31, 2018, stratified by any switch in AB use during index episode Table 2. Primary outcomes of uncomplicated UTI outpatients during January 1, 2013–December 31, 2018, stratified by any switch in AB use during 12-month follow-up Conclusion US females with uUTI who switched AB had more rUTI cases and increased overall costs and HRU compared with those who did not switch AB, suggesting an unmet need for improved prescribing practices. Disclosures Rena Moon, MD, Premier Applied Sciences, Premier Inc. (Employee) Alen Marijam, MSc, GlaxoSmithKline plc. (Employee, Shareholder) Fanny S. Mitrani-Gold, MPH, GlaxoSmithKline plc. (Employee, Shareholder) Daniel C. Gibbons, PhD, GlaxoSmithKline plc. (Employee, Shareholder) Alex Kartashov, PhD, Premier Applied Sciences, Premier Inc. (Employee) Ning Rosenthal, MD, Premier Applied Sciences, Premier Inc. (Employee, Shareholder) Ashish V. Joshi, PhD, GlaxoSmithKline plc. (Employee, Shareholder)

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Real-World Survival Among Patients with Intermediate- to High-Risk Myelofibrosis in the United States: Impact of Ruxolitinib Approval

Blood ◽

10.1182/blood-2020-140820 ◽

2020 ◽

Vol 136 (Supplement 1) ◽

pp. 46-47

Author(s):

Srdan Verstovsek ◽

Shreekant Parasuraman ◽

Jingbo Yu ◽

Anne Shah ◽

Shambhavi Kumar ◽

...

Keyword(s):

High Risk ◽

Real World ◽

Research Funding ◽

Index Date ◽

Time Frame ◽

Publicly Traded ◽

Approval Time ◽

Risk Of Mortality ◽

Death Date

Background The myeloproliferative neoplasm myelofibrosis (MF) is associated with reduced overall survival (OS) compared with the general population (Hultcrantz M, et al. J Clin Oncol. 2012;30[24]:2995-3001; Price GL, et al. PLoS One. 2014;9[3]:e90299). The Janus kinase 1 and 2 inhibitor ruxolitinib (RUX) was approved by the US Food and Drug Administration in November 2011 for the treatment of adult patients with intermediate- or high-risk MF based on data from the phase 3 COMFORT trials, which showed significantly improved OS in patients who received RUX (Verstovsek S, et al. J Hematol Oncol. 2017;10:156). Understanding the clinical benefit of RUX in real-world practice requires an understanding of changes in patient outcomes for those exposed to RUX compared with those never exposed to RUX, both before and after approval. The aim of this analysis was to assess the OS of patients newly diagnosed with intermediate- to high-risk MF before RUX approval, and for those who were RUX-unexposed vs -exposed in the post-RUX approval time frame. Study Design and Methods All data from the Medicare Fee-for-Service claims database (Parts A/B/D) from January 2010 to December 2017 were used to identify patients who were ≥65 years old (intermediate-1 or higher risk MF due to age) with ≥1 inpatient claim or ≥2 outpatient claims with a documented MF diagnosis. The index date was the date of the first qualifying MF claim; ≥12 months of pre-index continuous medical and pharmacy enrollment was required. Patients with evidence of an MF diagnosis ≤12 months before the index date were excluded. Patients with a diagnosis of myelodysplastic syndrome, hematologic malignancies (leukemias, multiple myeloma, and lymphomas), or solid tumors either ≤12 months before, on, or any time after index were also excluded in a stepwise manner. The study sample was classified into 3 groups: patients diagnosed with MF pre-RUX approval (index year 2010-2011; no post-index exposure to RUX); those diagnosed with MF post-RUX approval and unexposed to RUX (index year 2012-2017); and those diagnosed with MF post-RUX approval and exposed to RUX (index year 2012-2017). One-year survival rate and risk of mortality were estimated using Kaplan-Meier and Cox proportional hazards regression analyses, adjusting for baseline demographic and clinical characteristics. OS was measured from the index date until death or end of follow-up. Patients without a death date were censored at disenrollment or the end of the study period, whichever occurred first. Results Among eligible patients with an MF diagnosis (N=1677), median age was 78 years, 39.8% were male, and 84.1% were white. The analysis included 278 patients diagnosed pre-RUX approval (all RUX-unexposed) and 1399 diagnosed post-RUX approval (RUX-unexposed, n=1127; RUX-exposed, n=272). Median follow-up for the pre- and post-RUX approval groups was 12.5 and 11.3 mo (RUX-unexposed, 10.2 mo; RUX-exposed, 14.0 mo), respectively. In the pre-RUX approval group, 119 (42.8%) patients had a valid death date compared with 436 (31.2%) in the post-RUX approval group (RUX unexposed, n=382 [33.9%]; RUX exposed, n=54 [19.9%]). The 1-year survival rate (95% CI) was 55.6% (49.4%-61.3%) for the pre-RUX approval group, 72.5% (69.5%-75.2%) for the post-RUX approval RUX-unexposed group, and 82.3% (76.7%-86.7%) for the post-RUX approval RUX-exposed group (Figure). The risk of mortality was lowest among RUX-exposed patients (adjusted hazard ratio [HR], 0.36; 95% CI, 0.26-0.50; P<0.0001 vs the pre-RUX approval group). Patients in the post-RUX approval group who had never been exposed to RUX also had a lower risk of mortality, although less pronounced than RUX-exposed patients, compared with the pre-RUX approval group (adjusted HR, 0.67; 95% CI, 0.56-0.80; P<0.0001). Conclusions In this real-world study of US patients diagnosed with intermediate- or high-risk MF, 1-year OS was improved in patients diagnosed after RUX approval compared with before RUX approval. Notably, in the post-RUX approval time frame, 1-year OS was greater for those who received RUX than for those who did not receive RUX. These findings complement the survival benefit results demonstrated in the COMFORT studies using real-world data. Disclosures Verstovsek: Gilead: Research Funding; NS Pharma: Research Funding; Genentech: Research Funding; Incyte Corporation: Consultancy, Research Funding; CTI Biopharma Corp: Research Funding; Celgene: Consultancy, Research Funding; Sierra Oncology: Consultancy, Research Funding; AstraZeneca: Research Funding; ItalPharma: Research Funding; Protagonist Therapeutics: Research Funding; PharmaEssentia: Research Funding; Blueprint Medicines Corp: Research Funding; Novartis: Consultancy, Research Funding; Roche: Research Funding; Promedior: Research Funding. Parasuraman:Incyte Corporation: Current Employment, Current equity holder in publicly-traded company. Yu:Incyte Corporation: Current Employment, Current equity holder in publicly-traded company. Shah:Avalere Health: Current Employment. Kumar:Avalere Health: Current Employment; Incyte Corporation: Other: Avalere Health is a paid consultant of Incyte Corporation. Xi:Avalere Health: Current Employment; Incyte Corporation: Other: Avalere Health is a paid consultant of Incyte Corporation. Harrison:Gilead Sciences: Honoraria, Speakers Bureau; CTI Biopharma Corp: Honoraria, Speakers Bureau; Shire: Honoraria, Speakers Bureau; Novartis: Honoraria, Research Funding, Speakers Bureau; Roche: Honoraria; Sierra Oncology: Honoraria; Celgene: Honoraria, Research Funding, Speakers Bureau; Janssen: Speakers Bureau; Incyte Corporation: Speakers Bureau; AOP Orphan Pharmaceuticals: Honoraria; Promedior: Honoraria.

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1414. Real-World Study of Healthcare Resource Use and Costs Associated with Inappropriate and Suboptimal Antibiotic Use Among Females with Uncomplicated Urinary Tract Infection in the United States

Open Forum Infectious Diseases ◽

10.1093/ofid/ofab466.1606 ◽

2021 ◽

Vol 8 (Supplement_1) ◽

pp. S792-S792

Author(s):

Madison T Preib ◽

Fanny S Mitrani-Gold ◽

Xiaoxi Sun ◽

Christopher Adams ◽

Ashish V Joshi

Keyword(s):

Urinary Tract ◽

Resource Use ◽

Real World ◽

Index Date ◽

Healthcare Resource ◽

Healthcare Resource Use ◽

Population Total ◽

The Us ◽

Commercial Population

Abstract Background Urinary tract infections (UTIs) are the most common outpatient infection requiring medical care in the US; but, despite Infectious Diseases Society of America 2011 guidelines for treating uncomplicated UTI (uUTI), variation in prescribing practices still exists. Few studies have used real-world data (RWD) to evaluate uUTI-associated healthcare resource use (HRU) and costs. We examined HRU and direct costs associated with appropriate and optimal (AP&OP) and inappropriate or suboptimal (IA/SO) antibiotic (AB) prescribing in females with uUTI using US RWD. Methods This retrospective cohort study used RWD from IBM MarketScan (commercial/Medicare claims) to examine uUTI-related HRU and costs (inpatient, emergency room, outpatient, pharmacy) per index uUTI episode and during 1-year follow-up among females (age ≥ 12 years) diagnosed with uUTI from July 1, 2013–December 31, 2017 (index date). Patients had an oral AB prescription ± 5 days of the index date, and continuous health plan enrollment ≥ 6 months pre/1 year post-index date; those with complicated UTI were excluded. Patients were stratified by AB prescription as follows: AP&OP = guideline-compliant and correct duration; IA/SO = guideline non-compliant/incorrect duration or re-prescription/switch within 28 days. Results The study included 557,669 patients. In the commercial population (n=517,664, mean age 37.7 years), fewer patients were prescribed AP&OP (11.8%) than IA/SO (88.2%) ABs, a trend also seen in the Medicare population (n=40,005, mean age 74.5 years). In both populations, adjusted average numbers of uUTI-related ambulatory visits and pharmacy claims were lower for the AP&OP cohort than the IA/SO cohort during index episode and 1-year followup (p < 0.0001, Table 1). In the commercial population, total adjusted uUTI-related costs were &194 (AP&OP) versus &274 (IA/SO; p < 0.0001); in the Medicare population, total adjusted uUTI-related costs were &253 (AP&OP) versus &355 (IA/SO; p < 0.0001) (Table 2). Table 1. uUTI-related HRU for commercial and Medicare populations calculated using the GLM model Table 2. uUTI-related costs for commercial and Medicare populations calculated using the GLM model Conclusion Overall uUTI-related HRU and costs in the US were low during index episodes and follow-up. However, females with uUTI prescribed IA/SO ABs were more likely to incur higher HRU and costs than those prescribed AP&OP ABs, suggesting an unmet need for training to optimize uUTI prescribing per US guidelines. Disclosures Madison T. Preib, MPH, STATinMED Research (Employee, Former employee of STATinMED Research, which received funding from GlaxoSmithKline plc. to conduct this study) Fanny S. Mitrani-Gold, MPH, GlaxoSmithKline plc. (Employee, Shareholder) Xiaoxi Sun, MA, STATinMED Research (Employee, Employee of STATinMED Research, which received funding from GlaxoSmithKline plc. to conduct this study) Christopher Adams, MPH, STATinMED Research (Employee, Employee of STATinMED Research, which received funding from GlaxoSmithKline plc. to conduct this study) Ashish V. Joshi, PhD, GlaxoSmithKline plc. (Employee, Shareholder)

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Undesirable effects and persistence of gliflozine treatment in patients with type 2 diabetes mellitus

The Journal of AMD ◽

10.36171/jamd20.23.2.2 ◽

2020 ◽

Vol 23 (2) ◽

pp. 102

Author(s):

De Mori, v.

Keyword(s):

Type 2 Diabetes ◽

Urinary Tract ◽

Urinary Tract Infections ◽

Plasma Glucose ◽

Real World ◽

Sglt2 Inhibitors ◽

Tract Infections ◽

Demographic Features

OBJECTIVE OF THE STUDY SIDECAR (SGLT2-Inhibitors in Diabetes: Evaluation of metabolic Control and Adverse events in the Real-world), is a monocentric prospective observational study performed to monitoring in clinical practice patients with type 2 diabetes (T2D) treated with SGLT2-i to evaluate metabolic and anthropometric evolution during time, as well as the onset of adverse effects (AEs). Design and methods. Demographic features, T2D duration, and clinical parameters at baseline have been recorded as mean ± Standard Deviation (SD) for continuous variables, and frequency distribution for discrete variables. A repeated measures regression model was utilized for the evolution during time of parameters. AEs prevalence were recorded with stratification for main clinical and demographic features at baseline. RESULTS N=220 patients, with 18 months available follow-up, treated with SGLT2-i (N= 19 canagliflozin, 8.6%; N=91 dapagliflozin, 41.4%; N=110 empagliflozin, 50%) monotherapy or in combination according to AIFA indications). Really effective was the action of SGLT2-i on glucose metabolism, with rapid reduction in HbA1c and fasting plasma glucose after 6 months, as well as after 12 and 18 months (HbA1c: -1,0%; fasting plasma glucose: -34,8mg/dL). Weight and BMI showed a satisfying improvement, while waist circumference was statistically significant only after 12 months. Blood pressure, total cholesterol, and renal function were not modified by the treatment. But, apart from the valuable effects on metabolic parameters, 86 patients (39%) suspended SGLT2-i treatment mainly because ineffectiveness (15,7%) or for Genito-Urinary Tract Infections (GUTIs) appearance (14,3%). CONCLUSIONS Median term follow-up confirms the efficacy of SGLT2-i, but a significant percentage of patients is forced to suspend these drugs especially for GUTIs appearance. Such high prevalence of non-serious AEs limits the potential nephro-cardiovascular benefits related to SGLT2-i utilization. A possible chance to reduce GUTIs should come from single tablet association of SGLT2-i and DPP4-i actually available on the market. KEY WORDS type 2 diabetes; SGLT2 inhibitors; genito-urinary tract infections; real world evaluation; health education

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1435. Unmet Needs in Uncomplicated Urinary Tract Infection in the United States and Germany: A Physician Survey

Open Forum Infectious Diseases ◽

10.1093/ofid/ofab466.1627 ◽

2021 ◽

Vol 8 (Supplement_1) ◽

pp. S799-S800

Author(s):

Megan O’Brien ◽

Alen Marijam ◽

Fanny S Mitrani-Gold ◽

Laura Terry ◽

Gavin Taylor-Stokes ◽

...

Keyword(s):

Urinary Tract ◽

Real World ◽

Unmet Needs ◽

Symptom Relief ◽

The United States ◽

Prescribing Patterns ◽

Complete Relief ◽

Uncomplicated Urinary Tract Infection ◽

Exclusion Criteria ◽

Tract Infections

Abstract Background Uncomplicated urinary tract infections (uUTI) are one of the most common bacterial infections in women. Understanding unmet needs of physicians in diverse healthcare systems is important for developing novel uUTI treatment (tx). Methods A cross-sectional survey of physicians in the US and Germany (DE). Physicians were recruited via specialist panel and the survey was piloted (1 US, 1 DE physician) prior to recruitment. Primary objectives were understanding physician tx goals, management approaches, and prescribing patterns for uUTI. Secondary objectives included understanding perceptions of uUTI impact on patients and awareness of antibiotic (AB) resistance. Descriptive statistics were used for analysis. See Table for inclusion/exclusion criteria. Table. Physician inclusion and exclusion criteria Results Overall, 300 physicians (200 US, 100 DE) were surveyed. Symptom relief was in the top 3 (of 5) most important outcomes for ≥ 90% of physicians (US and DE); clearing infection was a top 3 outcome for 85% of US and 60% of DE physicians (Fig. 1). Physicians estimated ~20% of patients do not achieve complete relief from initial AB tx. Generally, urinalysis, dip stick, and symptom review were most commonly used in diagnosis, with culture and AB susceptibility tests mostly used to aid tx decisions (Fig. 2). For first-line AB, US physicians reported trimethoprim-sulfamethoxazole (TMP-SMX; 76%) and nitrofurantoin (57%) as most prescribed; in DE, fosfomycin (61%) and TMP-SMX (50%) were prescribed most. In both countries, ciprofloxacin (US 51%, DE 45%) was most prescribed after ≥ 2 tx failures. On a scale of “very poor” (1) to “exceptional” (7) for tx and management of uUTI, 58% of US physicians gave TMP-SMX a 6 or 7, and 62% of DE physicians gave fosfomycin a 6 or 7. More than 33% of physicians believed patients’ quality of life was greatly impacted by 1 tx failure, rising to 60% of physicians for 2 tx failures, and 73% for ≥ 3. Most physicians (72% US, 83% DE) agreed that development of AB resistance was serious (Fig. 3), but fewer (56% US, 46% DE) were confident in their knowledge of AB resistance. Figure 1. Treatment goal considered in the top 3 most important goals by physicians for managing patients with uUTI Figure 2. Use of diagnosis (A) and treatment decision (B) aids Figure 3. Physicians’ opinions on antibiotic resistance Conclusion Symptom relief was the primary uUTI tx goal for physicians. Physicians recognized that patients are greatly impacted by tx failure and AB resistance is a serious problem, but many were not confident or had insufficient information on AB resistance. Disclosures Megan O’Brien, BA, Adelphi Real World (Employee, Employee of Adelphi Real World, which received funding from GlaxoSmithKline plc. to conduct this study) Alen Marijam, MSc, GlaxoSmithKline plc. (Employee, Shareholder) Fanny S. Mitrani-Gold, MPH, GlaxoSmithKline plc. (Employee, Shareholder) Laura Terry, MSc, Adelphi Real World (Employee, Employee of Adelphi Real World, which received funding from GlaxoSmithKline plc. to conduct this study) Gavin Taylor-Stokes, MBA, Adelphi Real World (Employee, Employee of Adelphi Real World, which received funding from GlaxoSmithKline plc. to conduct this study) James Pike, B.Sc. Hons., M.Phil., Adelphi Real World (Employee, Employee of Adelphi Real World, which received funding from GlaxoSmithKline plc. to conduct this study) Ashish V. Joshi, PhD, GlaxoSmithKline plc. (Employee, Shareholder)

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Does cranberry extract reduce antibiotic use for symptoms of acute uncomplicated urinary tract infections (CUTI)? A feasibility randomised trial

BMJ Open ◽

10.1136/bmjopen-2020-046791 ◽

2021 ◽

Vol 11 (2) ◽

pp. e046791

Author(s):

Oghenekome Gbinigie ◽

Julie Allen ◽

Nicola Williams ◽

Michael Moore ◽

Alastair D Hay ◽

...

Keyword(s):

General Practice ◽

Urinary Tract ◽

Outcome Measures ◽

Randomised Trial ◽

Antibiotic Use ◽

Secondary Outcome ◽

Uncomplicated Urinary Tract Infection ◽

Tract Infections ◽

Lost To Follow Up

ObjectivesTo determine the feasibility of conducting a randomised trial of the effectiveness of cranberry extract in reducing antibiotic use by women with symptoms of acute, uncomplicated urinary tract infection (UTI).DesignOpen-label feasibility randomised parallel group trial.SettingFour general practices in Oxfordshire.ParticipantsWomen aged 18 years and above presenting to general practice with symptoms of acute, uncomplicated UTI.InterventionsWomen were randomly assigned using Research Electronic Data Capture in a 1:1:1 ratio to: (1) immediate antibiotics alone (n=15); (2) immediate antibiotics and immediate cranberry capsules for up to 7 days (n=15); or (3) immediate cranberry capsules and delayed antibiotics for self-initiation in case of non-improvement or worsening of symptoms (n=16).Primary and secondary outcome measuresThe primary outcome measures were: rate of recruitment of participants; numbers lost to follow-up; proportion of electronic diaries completed by participants; and acceptability of the intervention and study procedures to participants and recruiters. Secondary outcomes included an exploration of differences in symptom burden and antibiotic use between groups.ResultsFour general practitioner practices (100%) were opened and recruited participants between 1 July and 2 December 2019, with nine study participants recruited per month on average. 68.7% (46/67) of eligible participants were randomised (target 45) with a mean age of 48.4 years (SD 19.9, range 18–81). 89.1% (41/46) of diaries contained some participant entered data and 69.6% (32/46) were fully complete. Three participants (6.5%) were lost to follow-up and two (4.4%) withdrew. Of women randomly assigned to take antibiotics alone (controls), one-third of respondents reported consuming cranberry products (33.3%, 4/12). There were no serious adverse events.ConclusionsIt appears feasible to conduct a randomised trial of the use of cranberry extract in the treatment of acute, uncomplicated UTI in general practice.Trial registration numberISRCTN Registry (ID: 10399299).

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Real-world evaluation of costs of illness for pneumonia in adult patients in Dubai—A claims database study

PLoS ONE ◽

10.1371/journal.pone.0256856 ◽

2021 ◽

Vol 16 (9) ◽

pp. e0256856

Author(s):

Sara Ahmad Mohammad Al Dallal ◽

Mohamed Farghaly ◽

Ahmed Ghorab ◽

Mostafa Elaassar ◽

Hammam Haridy ◽

...

Keyword(s):

High Risk ◽

Real World ◽

Healthcare Costs ◽

Low Risk ◽

Emergency Visits ◽

Claims Database ◽

Medium Risk ◽

The Mean ◽

High Risk Cohort

Background Pneumonia is a significant cause of morbidity and mortality among adults globally. This retrospective cohort analysis assessed the pneumonia burden and related healthcare resource utilization and costs in the at-risk (low, medium, and high-risk) adult patients in Dubai, United Arab Emirates (UAE). Methods The claims data from January 1, 2014 to June 30, 2019 were extracted from the Dubai Real-World Claims Database for patients, aged ≥18 year, having at least 1 pneumonia claim. Data for the inpatient, outpatient and emergency visits were assessed for 12-months, before (pre-index) and after (follow-up) a pneumonia episode. Healthcare costs were calculated based on dollar value of 2020. Results Total 48,562 records of eligible patients were analyzed (mean age = 39.9 years; low [62.1%], medium [36.2%] and high [1.7%] risk cohorts). Mean all-cause healthcare costs were approximately >45% higher in the follow-up period (1,947 USD/patient) versus pre-index period (1,327 USD/patient). During follow-up period, the mean annual pneumonia incidence rate was 1.3 episodes, with a similar pattern across all cohorts. Overall, mean claims and costs (USD) per patient (all-cause) were highest in the high-risk cohort in the follow-up period (claims: overall, 11.6; high-risk, 22.0; medium-risk, 13.9; low-risk, 9.9; costs: high-risk, 14,184; medium-risk, 2,240; low-risk, 1,388). Similarly, the mean pneumonia-related costs (USD) per patient were highest for the high-risk cohort (overall: 1,305; high-risk, 10,207; medium-risk, 1,283; low-risk, 882), however, the claims were similar across cohorts (claims/patient: overall: 2.0; high-risk, 1.9; medium-risk, 2.2; low-risk, 1.9). Most all-cause and pneumonia-related costs were due to inpatient visits (4,901 and 4,818 USD respectively), while outpatient (1,232 and 166 USD respectively) and emergency visits (347 and 206 USD respectively) contributed significantly lesser. Conclusions Pneumonia imposes a significant healthcare burden in the UAE, especially in the high-risk patients with severe comorbidities. These findings would guide clinicians and policy makers to make informed decisions.

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Microbiome recovery in adult females with uncomplicated urinary tract infections in a randomised phase 2A trial of the novel antibiotic gepotidacin (GSK140944)

BMC Microbiology ◽

10.1186/s12866-021-02245-8 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Andrea Nuzzo ◽

Stephanie Van Horn ◽

Christopher Traini ◽

Caroline R. Perry ◽

Etienne F. Dumont ◽

...

Keyword(s):

Urinary Tract ◽

Urinary Tract Infections ◽

Human Microbiome ◽

Time Points ◽

Pharyngeal Cavity ◽

Adult Females ◽

Microbiome Diversity ◽

Antibiotic Drug ◽

Tract Infections

Abstract Background With increasing concerns about the impact of frequent antibiotic usage on the human microbiome, it is important to characterize the potential for such effects in early antibiotic drug development clinical trials. In a randomised Phase 2a clinical trial study that evaluated the pharmacokinetics of repeated oral doses of gepotidacin, a first-in-chemical-class triazaacenaphthylene antibiotic with a distinct mechanism of action, in adult females with uncomplicated urinary tract infections for gepotidacin (GSK2140944) we evaluated the potential changes in microbiome composition across multiple time points and body-sites (ClinicalTrials.gov: NCT03568942). Results Samples of gastrointestinal tract (GIT), pharyngeal cavity and vaginal microbiota were collected with consent from 22 patients at three time points relative to the gepotidacin dosing regimen; Day 1 (pre-dose), Day 5 (end of dosing) and Follow-up (Day 28 ± 3 days). Microbiota composition was determined by DNA sequencing of 16S rRNA gene variable region 4 amplicons. By Day 5, significant changes were observed in the microbiome diversity relative to pre-dose across the tested body-sites. However, by the Follow-up visit, microbiome diversity changes were reverted to compositions comparable to Day 1. The greatest range of microbiome changes by body-site were GIT followed by the pharyngeal cavity then vagina. In Follow-up visit samples we found no statistically significant occurrences of pathogenic taxa. Conclusion Our findings suggest that gepotidacin alteration of the human microbiome after 5 days of dosing is temporary and rebound to pre-dosing states is evident within the first month post-treatment. We recommend that future antibiotic drug trials include similar exploratory investigations into the duration and context of microbiome modification and recovery. Trial registration NCT03568942. Registered 26 June 2018.

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